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NCT03945019 · ClinicalTrials.gov registry record · Phase 3
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
A Phase 3 study, sponsored by Celltrion.
- Completed
- Registry status
- Phase 3
- Development phase
- 396
- Enrollment target
NCT03945019: Completed Phase 3 study, sponsored by Celltrion.
NCT03945019 is a Phase 3 study that has completed, run by Celltrion. The registered enrollment target is 396 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03945019, a Phase 3 study, has completed, sponsored by Celltrion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 396 participants
- Enrollment target
Study Summary
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
Primary Outcome
Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of \<150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as
Interventions
- OTHER Placebo SC
- BIOLOGICAL CT-P13 SC (Infliximab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2023-08-22 |
| Phase | Phase 3 |
What the finished NCT03945019 record still lists
NCT03945019 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo SC is the first listed.
NCT03945019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03945019 about?
NCT03945019 is a clinical study titled "CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)". This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
What is the current status of trial NCT03945019?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 396 participants. The study started on 2019-10-28. Estimated completion is 2023-08-22.
What interventions are being tested in trial NCT03945019?
The interventions under investigation include: Placebo SC (OTHER), CT-P13 SC (Infliximab) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03945019?
This trial is sponsored by Celltrion, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03945019's enrollment target sits among peer trials
396 964th of 2000 higher than 1,036 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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